Manager Medical Writing

Vor 6 Tagen

Allschwil, Schweiz Johnson & Johnson Vollzeit

**Manager Medical Writing**:
Position Summary:

- Able to write and coordinate complex documents within and across therapeutic areas (TAs) independently.
- Able to function as a lead writer on any compound with general supervision.
- Leads discussions in or leads process working groups.
- Actively participates in setting functional tactics/strategy.
- Provides input into TA-level strategy (eg, submission team, global program team, clinical team).
- Able to oversee the work of external contractors.
- If a people manager:

- Manages a team of internal medical writers.
- Accountable for the quality of deliverables and for compliance of direct reports.
- Actively participates in resource management and hiring decisions.

**Principal Responsibilities**:

- Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
- Leads cross-functional (eg, with clinical team) document planning and review meetings. Interacts with cross-functional colleagues on document content and champions MW processes and standard methodologies. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
- Proactively provides recommendations for departmental process improvements.
- Able to function as a lead writer on any compound (or submissions, indications, or disease areas) under supervision. Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
- Completes all time reporting, training, and metrics database updates as required in relevant company systems.
- If a people manager:

- Supervises/handles direct reports. Sets objectives for direct reports.
- Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
- Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.
- Performance oversight, feedback, and development, as well as accountability for direct reports.

**Principal Relationships**:

- Internal: manager, other writers, cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in preparation and planning of clinical documents. May interact with senior cross-functional leaders for coordination between departments.
- External: May oversee day-to-day work of contractors or external service providers as needed. May collaborate with external partner company staff on codeveloped compounds.
- Supervision (direct): Direct reports (if applicable), and others as assigned.

**Qualifications**
**Education and Experience Requirements**:

- A university/college degree is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
- At least 8 years of relevant pharmaceutical/scientific experience is required.
- At least 6 years of relevant clinical/regulatory medical writing experience is required.
- 0-2 years of people management experience if a people manager.

**Other**:

- Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in sophisticated document types independently.
- Resolves complex problems under general supervision.
- If manager of direct reports, lead discussions about direct report goal-setting, performance evaluations and ratings, promotions, salary adjustments, in close interaction with TA head.
- Excellent oral and written communication skills.
- Ability to lead in a team environment.
- Experienced time management for self and teams.
- Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.
- Demonstrates learning agility.

**Who We Are**:
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of o

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